Quality Operations Specialist

Company: Hays
Location: Cambridge
Posted on: February 24, 2021

Job Description:

Quality Operations Specialist - Perm - Cambridge, MA - $100,000-$140,000
The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.
A Biotechnology Company is seeking a Quality Operations Specialist in Cambridge, MA.
Role Description
Looking for Quality Operations Specialists to join their growing Quality group. In this role, the candidate will be responsible for providing appropriate oversight to ensure cGMP compliance of clinical cell therapy products produced. The Specialist provides a link between operations and the various quality systems. The primary responsibility is to directly support Operations through real-time, on-line batch record QA review and approval.
--- Provide on-the-floor QA oversight in GMP cleanroom and laboratory environments and support to ensure compliance to GMP regulations throughout those areas.--- Perform quality walk-throughs and process observations.--- Perform receipt and disposition of incoming patient apheresis material.--- Perform issuance verification of production documents and labels, to meet production schedule.--- Ensure timely resolution and escalation of issues within the operational areas.--- Ensure products are manufactured in compliance with regulatory and GMP guidelines.--- Ensure all product-related Deviations are initiated, investigated and resolved.--- Ensure that associated CAPAs are initiated and resolved.--- Perform lot closure and disposition activities.--- Ensure approval and timely delivery of final product.--- Oversee the shipping process and perform final product shipment authorization.--- Identify compliance risks and escalate the issues to appropriate levels of management for resolution.
Skills & Requirements
--- BA/BS degree with 5-7 years of experience in n a pharmaceutical, biotechnology or biologics operation.--- Experience in Viral Vectors, Cellular & Gene Therapy Products.--- Working knowledge and ability to apply GMPs.--- Strong teamwork and collaborative skills.--- Experience with manufacturing investigations, deviations, and CAPA.--- Experience with change control practices and strategies.--- Strong knowledge with aseptic manufacturing processes--- Experience in electronic Enterprise Management systems, Quality Management Systems, Document Management Systems.
Why Hays?
You will be working with a professional recruiter who has intimate knowledge of the Information Technology industry and market trends . Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there's a position you really want, you're fully prepared to get it.
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Hays is an Equal Opportunity Employer.
Drug testing may be required; please contact a recruiter for more information.

Keywords: Hays, Cambridge , Quality Operations Specialist, Other , Cambridge, Massachusetts